Usual Adult Dose for Contraception

1 tablet orally once a day

Comments:

• To be taken at the same time each day.
• Correct and consistent use can result in low failure rates.
• Withdrawal bleeding usually occurs within 3 days after discontinuing active tablets.

Usual Pediatric Dose for Contraception

1 tablet orally once a day

Comments:

• To be taken at the same time each day.
• Correct and consistent use can result in low failure rates.
• Withdrawal bleeding usually occurs within 3 days after discontinuing active tablets.

Renal Dose Adjustments

Use with caution; other methods of contraception should be considered in patients with renal disease.

Liver Dose Adjustments

Active liver disease: Contraindicated

Precautions

US BOXED WARNING: SERIOUS CARDIOVASCULAR ADVERSE EFFECTS:

• Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.

Dialysis

Data not available

Other Comments

Administration advice:

• For maximum effectiveness, this drug must be taken exactly as directed and at intervals not exceeding 24 hours.
• Tablets should be taken at the same time each day.
• The active tablets are to be taken consistently once a day for 21 days, followed by the inert tablets once a day for 7 days.
• Backup birth control should be used until the active tablets have been taken consistently for 7 days; some manufacturers recommend using a backup method for the first 7 days in either administration course (i.e. day 1 start or Sunday start).
• Spotting or breakthrough bleeding may occur, however the same regimen should be continued as this type of bleeding is usually transient; however, if the bleeding is persistent or prolonged, a physician should be consulted.
• Pregnancy should be considered at the first missed period and ruled out before continuing use in any patient that has missed 2 consecutive periods.
• Some manufacturers recommend a Sunday start upon starting the first pack of oral contraceptives; the manufacturer product information should be consulted.
• Whichever method of administration is chosen (i.e. day 1 start or Sunday start), the patient should continue to start each subsequent pack on the same day of the week.

• Take the first active pill on the Sunday after the period starts, even if the patient is still bleeding; if the period begins on a Sunday, start the pack the same day.
• A backup form of birth control (e.g., condoms) should be used from the Sunday the pills are started to the next Sunday (7 days)

• Take the first active pill during the first 24 hours of starting the period.
• A backup method of birth control will not be necessary with the Day 1 start.

• If 1 active pill is missed, take it as soon as it is remembered and the next pill at the regular time (2 pills in 1 day); a backup birth control method is not necessary
• If 2 active pills are missed in a row on week 1 or week 2 of the pack, take 2 pills on the day they are remembered and 2 pills the next day, then 1 pill each day until the pack is finished; a form of back-up birth control is necessary for the next 7 days
• If 2 active pills are missed in a row on Week 3, or 3 or more pills are missed in a row, the rest of the pill pack should be thrown out and a new pack started the same day for Day 1 starters; for Sunday starters, keep taking 1 pill every day until Sunday, then on Sunday, throw out the rest of the pack and start a new pack of pills the same day; back-up birth control is necessary for the next 7 days

• The use of oral contraceptives is associated with increased risks of serious conditions including myocardial infarction, thromboembolism, stroke, hepatic neoplasia, gallbladder disease, and hypertension; although risk of serious morbidity or mortality is low in healthy women without underlying risk factors.
• The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as hypertension, hyperlipidemias, obesity, and diabetes.
• Noncontraceptive health benefits related to oral contraceptives include: increased menstrual cycle regularity, decreased blood loss, decreased incidence of iron-deficiency anemia, decreased incidence of dysmenorrhea, decreased incidence of functional ovarian cysts, decreased incidence of ectopic pregnancies, decreased incidence of fibroadenomas and fibrocystic disease of the breast, decreased incidence of acute pelvic inflammatory disease, decreased incidence of endometrial cancer, and decreased incidence of ovarian cancer.

• This drug does not protect against HIV infection, AIDS, and other sexually transmitted diseases.
• Smoking while using this drug is not recommended as it increases the risk of thromboembolism.
• Consult your physician if you are breastfeeding; some authorities recommend to not initiate this medication until 4 to 6 weeks after a full-term delivery.
• If pregnancy is terminated in the first 12 weeks, oral contraceptives should be initiated immediately or within 7 days.
• If pregnancy is terminated after 12 weeks, oral contraceptives should be initiated after 2 weeks.
• The patient information leaflet should be consulted for further information.